Cleared Traditional

K060462 - NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)

K060462 is an FDA 510(k) clearance for NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN..., manufactured by Lab Vision Corp.. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K060462 · Lab Vision Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
61d
Days
Class 2
Risk

K060462 is an FDA 510(k) clearance for the NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE.... Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Lab Vision Corp. (Fremont, US). The FDA issued a Cleared decision on April 24, 2006 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lab Vision Corp. devices

FDA 510(k) Submission Details - K060462

510(k) Number K060462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date April 24, 2006
Days to Decision 61 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 78d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXZ Device Classification - Class 2, Special Controls

Product Code MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

All 12
Devices cleared under the same product code (MXZ) and FDA review panel - the closest regulatory comparables to K060462.
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861 · Dako North America, Inc. · Dec 2013
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K103818 · Ventana Medical Sytems, Inc. · Nov 2011
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
K062615 · Vision Biosystems, Inc. · Jan 2007
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884 · Dakocytomation California, Inc. · Feb 2005
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960 · Biogenex Laboratories · Mar 2002
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023 · Dako Corp. · Feb 2002